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| ID | Type | Description | Link |
|---|---|---|---|
| AshoushS | Other Identifier | personal | |
| IbrahimK | Other Identifier | personal | |
| ElhawariG | Other Identifier | personal |
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130 pregnant women with Iron deficiency anemia, in the 2nd trimester (microcytic hypochromic anemia, hemoglobin range from 9-10.5g/dl, serum ferritin less than 12 ng/ml), from the outpatient clinics in the Obstetrics and Gynecology Department, in Ain Shams University Hospital, Cairo, Egypt, will be enrolled and distributed into one of 2 groups by a computer generated random number table. Each of the 2 groups will receive 2 medication for 2 months with specific instruction to increase iron absorption. One group named L will receive powders of bovine lactoferrin and tablets of placebo form, the 2nd named F will receive ferrous sulphate tablet and placebo in powder form. Hemoglobin concentration, packed-cell volume (PCV) , mean cell volume (MCV), mean corpuscular hemoglobin (MCH), mean cell hemoglobin concentration (MCHC), Serum ferritin will be done at the start and the end of the treatment period.
The study will includes130 pregnant women, from the outpatient clinics in the Obstetrics and Gynecology Department, in Ain Shams University Hospital, Cairo, Egypt. Women should be diagnosed as having iron deficiency anemia, in the 2nd trimester (complete blood count, showing microcytic hypochromic anemia, hemoglobin range from 9-10.5, serum ferritin less than 12 ng/ml). Women will be enrolled and distributed into one of 2 groups by a computer generated random number table. Each of the 2 groups will receive 2 medication for 2 months with specific instruction to increase iron absorption. One group named L will receive powders of bovine lactoferrin and tablets of placebo form, the 2nd named F will receive ferrous sulphate tablet and placebo in powder form. Hemoglobin concentration, PCV, MCV, MCH, MCHC, Serum ferritin will be done at the start and the end of the treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| L (lactoferrin in IDA with pregnancy) | Experimental | Pregnant women with IDA, in the 2nd trimester are enrolled and treated for 2 months regularly with oral administration of 100 mg bLf granules (Pravotin sachets , Hygint, Egypt) in 1/4 glass of water twice a day before meals in addition to placebo tablets three time per day on an empty stomach. |
|
| F (ferrous sulphate with pregnancy) | Active Comparator | Pregnant women with IDA, in the 2nd trimester are enrolled and treated for 2 months regularly with oral administration of 150 mg of dried ferrous sulphate capsules (Ferrofol capsules, Eipico, Egypt), one capsule three times daily on an empty stomach, at least 1 hour before or 2 hours after meals, in addition to placebo sachets (starch) twice a day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| L (lactoferrin) | Dietary Supplement | Dietary Supplement: Pravotin sachets (Hygint, Egypt) containing bLf One sachet of Pravotin contains 100 mg of bLf. Dosage: one sachet twice a day before meals with placebo tablets |
| Measure | Description | Time Frame |
|---|---|---|
| change in Hemoglobin concentration | grams/dL | At time 0 (enrollment),1 and 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Serum ferritin | nanograms per milliliter | At time 0 (enrollment) and 2 months |
| mean cell volume (MCV) | fL/red cell in adult | At time 0 (enrollment) and 2 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mai M Abdelwahed, specialist | Contact | 01152684127 | 002 | maya_mohamed0@hotmail.com |
| Gihan E El Hawwary, specialist | Contact | 01210333986 | 002 |
| Name | Affiliation | Role |
|---|---|---|
| Sherif A Ashoush, a. professor | personal | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mai Mahmoud Mohamed | Recruiting | Alexandria | 12345 | Egypt |
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| ID | Term |
|---|---|
| D007781 | Lactoferrin |
| C020748 | ferrous sulfate |
| ID | Term |
|---|---|
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
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| F (ferrous sulphate) | Drug | Drug: FerroGrad by Abbott Dosage: one capsule three times /day containing150 mg of dried ferrous sulfate capsules (Ferrofol capsules, Eipico, Egypt), with placebo sachets. |
|
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| mean corpuscular hemoglobin (MCH) | picograms (pg)/cell in adults | At time 0 (enrollment) and 2 months |
| mean cell hemoglobin concentration (MCHC) | g/dL | At time 0 (enrollment) and 2 months |
| cost | The average drug cost by LE. | 1-2 months |
| percentage of women who agree to take each of the two drugs for a future whole pregnancy. | percentage | At time 0 (enrollment) and every 2 weeks, for 2 months |
| Side effects: | scaling score of side effects of oral administration of bLf and ferrous sulfate as:
| At time 0 (enrollment) and every 2 weeks, for 2 months |
| D004798 |
| Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D061250 | Transferrins |
| D033862 | Iron-Binding Proteins |
| D002352 | Carrier Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D007782 | Lactoglobulins |
| D000067816 | Whey Proteins |
| D008894 | Milk Proteins |
| D000080224 | Animal Proteins, Dietary |
| D004044 | Dietary Proteins |
| D005916 | Globulins |
| D008667 | Metalloproteins |